: what was the U.S. public health crises that drove the change in the law;
• Rule: what was the change in the law called, the year is was enacted, what were the major
features of the law;
• Analysis: what is the importance and legacy of this statutory change (this relates to the las9ng
impact of the statutory change that occurred; how did this law change how drugs or biologics
are regulated and contribute to protec9ng the public health?)
• Conclusion: have we learned anything since this public health crises?
Sample Solution